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Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab (COMIG)

Primary Purpose

Migraine

Status
Withdrawn
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
erenumab 70mg/mL
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring Chronic migraine, Migraine, Transformative migraine, Neurologic disease, Unremitting pain, Progressive over time, Nausea, Vomiting, Sensitivity to light,, Sensitivity to sound, Pain localized to one side of head,, Painful headache, Pain in head, Head throbbing, Sinus headache, Pounding headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: key inclusion citeria

During the Screening Epoch:

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Adults ≥18 years of age upon entry into screening.
  3. Patient diagnosed with chronic and high -frequency episodic migraine (with or without aura) for at least 1 year prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3).
  4. Patient with a documented diagnosis in clinical history of one or more of the following comorbidities: chronic fatigue, fibromyalgia and/or IBS.
  5. Patients previously treated with other monoclonal antibodies for migraine can be included if the appropriate washout period according to product half-life has been done for each monoclonal antibody.

During the Baseline Epoch:

  1. Migraine frequency of ≥ 10 migraine days during the Baseline Epoch, confirmed by the eDiary.
  2. ≥ 80% eDiary compliance during the Baseline Epoch.

Exclusion Criteria: Key Exclusion criteria

  1. Older than 50 years of age at migraine onset.
  2. Unable to differentiate migraine from other headaches.
  3. History of cluster headache or hemiplegic migraine headache.
  4. Used a device, or procedure within 2 months prior to the start of or during baseline or during the treatment period.
  5. Use of other investigational drugs within 5 half-lives of enrollment or inappropriate washout period in case of monoclonal antibodies, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
  6. Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
  7. History or evidence of any other unstable or clinically significant medical condition that in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Other protocol-defined inclusion/exclusion criteria may apply at the end.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigational Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigatice Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

erenumab

Arm Description

Solution for s.c injection. Prefilled autoinjector

Outcomes

Primary Outcome Measures

Percentage of patients (in the overall population and by each comorbidity) who achieve a ≥5-point increase in the MSQ-RFR, MSQ-RFP domains and a ≥8-point increase in the MSQ-EF domain of the Migraine-Specific Quality of Life Questionnaire (MSQ 2.1)
MSQ 2.1 consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement. Comorbidities include fibromyalgia, chronic fatigue, and/or irritable bowel syndrome (IBS)

Secondary Outcome Measures

Association between MSQ 2.1 and other HRQoL scores in each comorbidity (fibromyalgia, chronic fatigue, and/or IBS).
Correlation between HRQoL scores in migraine questionnaire (MSQ 2.1) and HRQoL scores in each comorbidity questionnaire: fibromyalgia (Fibromyalgia Impact Questionnaire, FIQ), chronic fatigue (Short Form health survey, SF-12) and IBS (Irritable Bowel Syndrome Quality of Life, IBS-QOL) in all study visits.
Mean change in HRQoL
Health Related Quality of Life (HRQoL) in patients with migraine and at least once of these comorbitiy (fibromyalgia, chronic fatigue and irritable bowel syndrome [IBS])
Patient profile: number of migraine episodes/month
This description can help to understand the baseline characteristics of patients treated with erenumab and the relation with the outcomes
Duration and exposure of 70 and 140 mg doses of erenumab
Dosing information will be collected throughout the trial including dose modifications and missed doses to provide total exposure of drug over time.
Change in the mean number of migrane days per month from baseline to month 12
• Efficacy of erenumab will be assessed by migraine days.
Change in the mean number of days of use of acute migraine-specific medication per month from baseline to month 12
• Efficacy of erenumab.
Percentage of patients who achieve at least 50% or greater reduction in the mean number of migraine days per month from baseline to month 12.
• Efficacy of erenumab.

Full Information

First Posted
August 21, 2019
Last Updated
May 28, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04114630
Brief Title
Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab
Acronym
COMIG
Official Title
A 12-month Prospective, Phase IIIb, Multicenter, Open-label Clinical Trial to Assess Health-related Quality of Life (HRQoL) in Patients With Chronic or High-frequency Episodic Migraine Treated With Erenumab Who Present Associated Comorbidities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No patients were enrolled and global prioritization of pipeline and research strategy
Study Start Date
October 30, 2019 (Anticipated)
Primary Completion Date
December 6, 2021 (Anticipated)
Study Completion Date
January 7, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Migraine is a very common, neurological disorder, characterized by recurrent episodes of headache, potential progression to more frequent and severe attack patterns, and associated symptoms. In Spain, the prevalence rates are 12-13% and in women up to 17-18% Migraine has been shown to largely impair patient's Health-Related Quality of Life (HRQoL), affecting work, household chores, social activities and family life. Recurrent headache attacks and frequently persistent fear and concern about the next attack disrupt the patient's familial, occupational and social life, and reduce his/her expectations for career and financial future. The consequences of this loss of productivity is also shared in his/her private life with their family. For this reason, not only the clinical benefit but other dimensions as HRQoL or work affectation should be added to the study of the benefits of migraine treatment. Migraine pathophysiology pathways may be shared with other illness, such as fibromyalgia, chronic fatigue or Irritable Bowel Syndrome (IBS) . The purpose of the present clinical trial is to evaluate whether erenumab, at a target dose of 70 mg or 140 mg for a period of 12 months, impacts Health-Related Quality of Life (HRQoL) among patients withchronic migraine (CM) or High-Frequency Episodic Migraine (HFEM) who are affected with at least one comorbidity (fibromyalgia, fatigue and IBS). Data from this study, will provide additional information to help clinicians in treating patients with migraine and other illness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Chronic migraine, Migraine, Transformative migraine, Neurologic disease, Unremitting pain, Progressive over time, Nausea, Vomiting, Sensitivity to light,, Sensitivity to sound, Pain localized to one side of head,, Painful headache, Pain in head, Head throbbing, Sinus headache, Pounding headache

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erenumab
Arm Type
Experimental
Arm Description
Solution for s.c injection. Prefilled autoinjector
Intervention Type
Drug
Intervention Name(s)
erenumab 70mg/mL
Other Intervention Name(s)
AMG334
Intervention Description
Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors
Primary Outcome Measure Information:
Title
Percentage of patients (in the overall population and by each comorbidity) who achieve a ≥5-point increase in the MSQ-RFR, MSQ-RFP domains and a ≥8-point increase in the MSQ-EF domain of the Migraine-Specific Quality of Life Questionnaire (MSQ 2.1)
Description
MSQ 2.1 consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement. Comorbidities include fibromyalgia, chronic fatigue, and/or irritable bowel syndrome (IBS)
Time Frame
Baseline up to approximately 12 months
Secondary Outcome Measure Information:
Title
Association between MSQ 2.1 and other HRQoL scores in each comorbidity (fibromyalgia, chronic fatigue, and/or IBS).
Description
Correlation between HRQoL scores in migraine questionnaire (MSQ 2.1) and HRQoL scores in each comorbidity questionnaire: fibromyalgia (Fibromyalgia Impact Questionnaire, FIQ), chronic fatigue (Short Form health survey, SF-12) and IBS (Irritable Bowel Syndrome Quality of Life, IBS-QOL) in all study visits.
Time Frame
Baseline, month 3, 6 and 12.
Title
Mean change in HRQoL
Description
Health Related Quality of Life (HRQoL) in patients with migraine and at least once of these comorbitiy (fibromyalgia, chronic fatigue and irritable bowel syndrome [IBS])
Time Frame
Baseline, month 6 and 12.
Title
Patient profile: number of migraine episodes/month
Description
This description can help to understand the baseline characteristics of patients treated with erenumab and the relation with the outcomes
Time Frame
Baseline
Title
Duration and exposure of 70 and 140 mg doses of erenumab
Description
Dosing information will be collected throughout the trial including dose modifications and missed doses to provide total exposure of drug over time.
Time Frame
Baseline up to approximately 1 year
Title
Change in the mean number of migrane days per month from baseline to month 12
Description
• Efficacy of erenumab will be assessed by migraine days.
Time Frame
From baseline to month 12
Title
Change in the mean number of days of use of acute migraine-specific medication per month from baseline to month 12
Description
• Efficacy of erenumab.
Time Frame
From baseline to month 12.
Title
Percentage of patients who achieve at least 50% or greater reduction in the mean number of migraine days per month from baseline to month 12.
Description
• Efficacy of erenumab.
Time Frame
From baseline to month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: key inclusion citeria During the Screening Epoch: Signed informed consent must be obtained prior to participation in the study. Adults ≥18 years of age upon entry into screening. Patient diagnosed with chronic and high -frequency episodic migraine (with or without aura) for at least 1 year prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3). Patient with a documented diagnosis in clinical history of one or more of the following comorbidities: chronic fatigue, fibromyalgia and/or IBS. Patients previously treated with other monoclonal antibodies for migraine can be included if the appropriate washout period according to product half-life has been done for each monoclonal antibody. During the Baseline Epoch: Migraine frequency of ≥ 10 migraine days during the Baseline Epoch, confirmed by the eDiary. ≥ 80% eDiary compliance during the Baseline Epoch. Exclusion Criteria: Key Exclusion criteria Older than 50 years of age at migraine onset. Unable to differentiate migraine from other headaches. History of cluster headache or hemiplegic migraine headache. Used a device, or procedure within 2 months prior to the start of or during baseline or during the treatment period. Use of other investigational drugs within 5 half-lives of enrollment or inappropriate washout period in case of monoclonal antibodies, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures. History or evidence of any other unstable or clinically significant medical condition that in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. Other protocol-defined inclusion/exclusion criteria may apply at the end.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalicía
ZIP/Postal Code
41009
Country
Spain
Facility Name
Novartis Investigative Site
City
Cadiz
State/Province
Andalucia
ZIP/Postal Code
11009
Country
Spain
Facility Name
Novartis Investigative Site
City
Córdoba
State/Province
Andalucia
ZIP/Postal Code
14011
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Facility Name
Novartis Investigative Site
City
Valladolid
State/Province
Castilla León
ZIP/Postal Code
47005
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08003
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
L'Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novartis Investigative Site
City
Elda
State/Province
Comunidad Valenciana
ZIP/Postal Code
03600
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Novartis Investigational Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Lugo
State/Province
Galicia
ZIP/Postal Code
27003
Country
Spain
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novartis Investigative Site
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
Novartis Investigative Site
City
Santa Cruz de Tenerife
State/Province
Islas Canarias
ZIP/Postal Code
38010
Country
Spain
Facility Name
Novartis Investigative Site
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Novartis Investigative Site
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Novartis Investigative Site
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novartis Investigative Site
City
Baracaldo
State/Province
País Vasco
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
País Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Name
Novartis Investigatice Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab

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